NCHR Comments on Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development

September 11, 2023, NCHR supports the FDA’s draft guidance with key recommendations. NCHR urges the FDA to add standardized protocols for instances of participant non-adherence, disease flair up, and acute illness. NCHR also recommends including specific guidance for crossover clinical trial design and more objective measures for dietary compliance rather than food diaries to strengthen the quality of the clinical trials performed among the IEM patient population, reduce confounding, and improve data interpretability.

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NCHR Comments on Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination FDA Draft Guidance

September 11, 2023: Tattoos are common in the U.S. and almost half tattoo inks are contaminated. NCHR supports FDA’s draft guidance to improve the safety of tattoo ink and recommends that labels describing the links be available to consumers and sterile dilution techniques should be required and explained. NCHR urges FDA to develop an information toolkit to increase
consumer awareness about reporting any adverse reactions to tattoos.

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